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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Elastomeric
510(k) Number K131247
Device Name MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
Applicant
Mfs - Medical Flow Systems, Ltd.
Elt Bldg., Dora Industrial Zone, Shlomi 22832, Isral
Shlomi,  IL 22832
Applicant Contact OFER SHAY
Correspondent
Mfs - Medical Flow Systems, Ltd.
Elt Bldg., Dora Industrial Zone, Shlomi 22832, Isral
Shlomi,  IL 22832
Correspondent Contact OFER SHAY
Regulation Number880.5725
Classification Product Code
MEB  
Subsequent Product Code
MEA  
Date Received05/01/2013
Decision Date 08/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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